Greenlight Guru is the best modern QMS for medical device manufacturers under FDA Class II/III inspection. The product is well-designed, the workflows are tight, and the team understands regulated environments. The problem for everyone else: you're paying for Part 11 strict-mode e-signatures, design-control workflows, and 21 CFR 820 modules you don't need — and you're using Greenlight Guru because no one shipped a modern QMS for ISO 9001 shops. We did.
Greenlight Guru's deep value is in design control — DHF (Design History File), DMR (Device Master Record), risk management per ISO 14971, design verification + validation, and Part 11 strict-mode e-signatures throughout. For medical device companies, this is the right model. Their team genuinely understands FDA inspections.
If you're a job shop, an automotive Tier 2, an aerospace sub-tier, or a contract manufacturer pursuing ISO 9001 / AS9100 / IATF 16949 — Greenlight Guru is the wrong fit. The pricing reflects medical device risk + Part 11 compliance burden, which you don't carry. The design control workflows assume you're developing the product (most SMB manufacturers build to customer drawings). You end up with a $30k-$60k QMS that solves problems you don't have.
Ignite Lean ships every audit answer the ISO 9001 / AS9100 / IATF 16949 auditor will ask for: CAPA with effectiveness check, internal audit program, supplier SCAR, calibration register, training matrix, management review pack, engineering change notice, risk register, document control via versioned WI flow. NCs join to build records (no manual reconciliation). E-signatures are SHA-256 hash-chained (ISO 9001 / AS9100 grade, not Part 11 strict mode — that's on the upgrade path if you ever need it).
Pick Greenlight Guru if you manufacture FDA Class II or III medical devices. That's really the boundary. Their design control + Part 11 strict-mode pedigree is the best in the SMB-friendly QMS category for medical device. Don't pick them if you're an ISO 9001 job shop — you're buying a different product.
Greenlight Guru: best modern QMS for medical device companies. Ignite Lean: same audit-ready quality system, calibrated for the 95% of SMB manufacturers who aren't under FDA inspection. Different products for different audiences.
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